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Evaluation of the efficacy of Sivelestat sodium in patients with acute lung injury

Evaluation of the efficacy of Sivelestat sodium in patients with acute lung injury

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074438
Enrollment
Unknown
Registered
2023-08-07
Start date
2023-08-10
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute lung injury

Interventions

Experimental group:Conventional treatment+Iv sivelestat sodium
Control group:Conventional treatment

Sponsors

Fujian Medical University Union Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients with cardiovascular surgery in the age range of 18 to 75 years old, who simultaneously meet the following two conditions: 1) Meet the criteria for acute lung injury, characterized by: ? Hypoxemia: PaO2/FiO2 (arterial oxygen partial pressure/fraction of inspired oxygen) = 300; ? Chest X-ray showing bilateral infiltrates; ? If pulmonary artery wedge pressure can be measured, pulmonary artery wedge pressure = 18 mmHg; if unable to measure pulmonary artery wedge pressure, no clinical evidence of elevated left atrial pressure. 2) Meet the diagnostic criteria for systemic inflammatory response syndrome (SIRS), and have two or more of the following: ? Fever (body temperature > 38.3?) or hypothermia (body temperature 90 beats/min; ? Tachypnea, respiratory rate > 20 breaths/min; ? Leukocytosis (white blood cell count > 12×109/L) or leukopenia (white blood cell count 10% band forms (immature white blood cells).

Exclusion criteria

Exclusion criteria: 1. Congestive heart failure with pulmonary artery wedge pressure =18 mmHg or clinical evidence of elevated left atrial pressure. 2. Use of glucocorticoids in the 4 weeks prior to hospitalization. 3. History of previous chemotherapy. 4. History of liver disease or significant abnormalities in liver function at the time of enrollment (aspartate aminotransferase, alanine aminotransferase levels more than twice the normal value). 5. History of severe chronic respiratory diseases (including but not limited to chronic obstructive pulmonary disease, interstitial lung disease, etc.). 6. Recent diagnosis of leukopenia or thrombocytopenia within the past year. 7. Acquired immune deficiency syndrome (AIDS) comorbidity. 8. Concurrent renal failure requiring hemodialysis or peritoneal dialysis. 9. Known allergy to the components of intravenous levosimendan. 10. Participation in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Inflammatory factor;Expression of miR-503 and DUSP1 genes;Mechanical ventilation time;Oxygenation index;

Countries

China

Contacts

Public ContactChen Sheng

Fujian Medical University Union Hospital

1253454741@qq.com+86 133 6591 7660

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026